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NCT05867992 | Not yet recruiting | Traumatic Brain Injury


Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
Sponsor:

RenJi Hospital

Information provided by (Responsible Party):

JunfengfEng

Brief Summary:

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are: Which proteins and metabolites are differently expressed in TBI patients' serum? Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

Condition or disease

Traumatic Brain Injury

Intervention/treatment

Type of trauma

Detailed Description:

This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group. Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions: Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI) Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)}}

Study Type : Observational
Estimated Enrollment : 80 participants
Official Title : Proteomic and Metabolomic Detection and Analysis of Serum From Patients With Acute Severe Traumatic Brain Injury: A Prospective, Multicentered Study
Actual Study Start Date : April 1, 2024
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : June 30, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • With traumatic brain injury in 12Hrs for case group, or with traumatic bone fracture in 12 hours for control group.
  • The Glasglow Coma Scale ranges in 3-8 for case group.
  • Need to have routine laboratory examination of blood sample.
  • Patients or agents sign the informed consent.
Exclusion Criteria
  • With bone fracture for case group, or with brain injury for control group.
  • Have Orthopaedic history for case group, or have Neurological history for control group.
  • Death in 24 hours.
  • Immunosuppressed state.
  • Severe multiple organ dysfunction.
  • With infection.
  • Pregnant.

Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

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Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury

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Locations


Not yet recruiting

China, Shanghai

Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai, China, 201114

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